Therasense V. Becton Dickinson: A First Impression

By Rantanen, Jason; Petherbridge, Lee | Yale Journal of Law & Technology, Spring 2012 | Go to article overview
Save to active project

Therasense V. Becton Dickinson: A First Impression


Rantanen, Jason, Petherbridge, Lee, Yale Journal of Law & Technology


TABLE OF CONTENTS  INTRODUCTION I.   BACKGROUND      A. The Case      B. The En Banc Opinion II.  LAW AND POLICY ISSUES RAISED BY THERASENSE      A. A Patent Handout      B. Implications for Patent Quality      C. Implications for Patent Litigation      D. Implications for Patent Practitioners         1. Will Therasense Really Change Case Outcomes?         2. Will Therasense solve the Problem of Applicant            Overdisclosure?      E. What Does It All Mean? III. A Glimpse of the New Federal Circuit?      1. An Ex Post, not an Ex Ante Patent System      2. A More Political Federal Circuit?      3. A Pro-Patentee Federal Circuit? CONCLUSION 

INTRODUCTION

The purpose of this Article is to provide an early analysis of some of the most substantial law and policy concerns raised by the very recent en banc decision of the united states Court of Appeals for the Federal Circuit in the now-famous Therasense v. Becton Dickinson case. (1) The doctrinal issue central to the case is inequitable conduct, a judicially created doctrine developed to punish patent applicants who behave inappropriately during patent prosecution, the ex parte process of patent creation.

The core thesis of this Article is that Therasense could have a much more significant, complex, and nuanced impact on the legal infrastructure of American innovation than the opinion for the court appears to appreciate. In view of these complexities, the court may be too sanguine in its expectations for the instrumental effect of its decision. More specifically, there are few reasons to be confident that the new doctrinal regime imposed by Therasense is well crafted to remedy any putative problems encouraged by the old law. Moreover, there is much reason to believe that the new doctrine could aggravate existing problems with the patent system and establish new ones. In sum, this is a decision that holds the potential to erode the legal infrastructure of American innovation.

To enhance understanding of the concerns developed in the analysis, the first Part of this Article provides a background that explains the innovation context and history of the case and describes the relevant legal dispute. The second Part of this Article is devoted to an early analysis of substantial innovation law and policy concerns raised by the decision of the court. We finish with a brief third Part, in which we consider what the Therasense case might reveal about the "new" Federal Circuit.

I. BACKGROUND

United States Patent No. 5,820,551, the patent at the heart of Therasense v. Becton Dickinson, had its origins in a United Kingdom laboratory in the early 1980s. (2) There, a team of pioneering scientists came together to develop a groundbreaking way for diabetes patients to monitor their blood glucose levels--a crucial advance in the treatment of diabetes, a disease whose growth rate over the past few decades has reached epidemic proportions. To give a sense of the magnitude of the epidemic, government statistics show that in 1980, 5.6 million Americans were diagnosed with the difficult-to-manage and potentially debilitating disease; (3) by 2010, that number had climbed to a startling 18.8 million Americans (with another 7.0 million believed to be undiagnosed). (4)

The device developed by these scientists was simple and elegant. it began with the creation of an improved sensor coated with biochemical compounds that produced a tiny flow of electricity in the presence of glucose, an invention that led to patent number 4,545,382 in the United states and patent number EP 0 078 636 in Europe. The scientists next placed the new sensor on a test strip that could be inserted into a meter to produce a digital readout of the blood glucose level and then thrown out. (5) This innovation made it possible for anyone to test their blood glucose at any time, leading to a revolution in diabetes patient care. (6)

As with the sensor invention, the scientists sought a patent for the disposable test strip.

The rest of this article is only available to active members of Questia

Sign up now for a free, 1-day trial and receive full access to:

  • Questia's entire collection
  • Automatic bibliography creation
  • More helpful research tools like notes, citations, and highlights
  • Ad-free environment

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
Loading One moment ...
Project items
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

Cited article

Therasense V. Becton Dickinson: A First Impression
Settings

Settings

Typeface
Text size Smaller Larger
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

While we understand printed pages are helpful to our users, this limitation is necessary to help protect our publishers' copyrighted material and prevent its unlawful distribution. We are sorry for any inconvenience.
Full screen

matching results for page

Cited passage

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

Cited passage

Welcome to the new Questia Reader

The Questia Reader has been updated to provide you with an even better online reading experience.  It is now 100% Responsive, which means you can read our books and articles on any sized device you wish.  All of your favorite tools like notes, highlights, and citations are still here, but the way you select text has been updated to be easier to use, especially on touchscreen devices.  Here's how:

1. Click or tap the first word you want to select.
2. Click or tap the last word you want to select.

OK, got it!

Thanks for trying Questia!

Please continue trying out our research tools, but please note, full functionality is available only to our active members.

Your work will be lost once you leave this Web page.

For full access in an ad-free environment, sign up now for a FREE, 1-day trial.

Already a member? Log in now.

Are you sure you want to delete this highlight?